GlaxoSmithKline (NYSE: GSK) announced that the European Commission approved its novel topical antibacterial ALTARGO? (retapamulin ointment,1%) for the treatment of impetigo and infected small lacerations, abrasions or sutured wounds.
ALTARGO is first in a class of antibacterials called pleuromutilins to be approved for treatment of skin infections in humans, and is indicated for use twice daily for a five-day period (10 doses) in patients nine months of age and older. Other prescription topical antibacterials are used as often as three times daily for at least seven days, involving more than 21 doses.
“ALTARGO provides doctors with an effective new treatment option for uncomplicated skin infections requiring half as many doses in fewer days than other topical antibiotics,? said Andrew Witty, President, Pharmaceuticals Europe, at GSK. ?GSK is committed to developing new antibacterials like ALTARGO, because bacterial resistance to currently available medicines is at an increasingly high level.”
European Commission approval of ALTARGO results in a single marketing authorisation with unified labeling that is immediately valid in all 29 participating EU member states. The Commission?s decision follows a Positive Opinion by the European Medicines Agency?s (EMEA) Committee for Medicinal Products for Human Use (CHMP) in March 2007, recommending the product for approval.
ALTARGO will be used to treat bacterial infections most commonly caused by Staphylococcus aureus and Streptococcus pyogenes affecting small areas of skin. The impetigo indication is based primarily on the results of a double-blind, placebo-controlled clinical study demonstrating that the efficacy of ALTARGO was superior to placebo in adults and children. In a second pivotal study, ALTARGO was found to provide an effective course of therapy for impetigo compared to another commonly used topical antibacterial, fusidic acid. In two additional Phase III clinical trials, researchers examined the efficacy and safety of ALTARGO versus oral cephalexin for the treatment of infected abrasions, minor cuts and wounds in patients nine months of age and older.
In clinical studies in which a total of 2,150 patients with superficial skin infections applied ALTARGO, the most commonly reported adverse reaction was application site irritation, which affected approximately 1% of patients.
Impetigo is a highly contagious bacterial infection of the top layers of the skin. It is most common among children two to six years of age. The infection causes sores which fill with pus before breaking open and producing the characteristic honey-coloured or yellowish brown crusts. Impetigo spreads easily in schools and child care settings by direct contact with wounds, sores or nasal discharge from an infected person. Scratching may also facilitate the spread of the infection. Cuts, scratches, insect bites or other dermatological conditions, notably eczema, can leave skin vulnerable to bacterial infection, especially with Staphylococcus aureus or group A Streptococcus.